MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM; SCREW, FIXATION, BONE

Catalog Number	402.880S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: h4 device history part # 402.880s lot # 8l37935 manufacturing site: werk selzach logistik release to warehouse date: 13 jul 2021 expiration date: 01 jul 2031 supplier: (b)(4) a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part a manufacturing record evaluation was performed for the finished device product code: 402.880 lot number: 269p014 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 06-jul-2021 manufacturing site: jabil grenchen device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported on (b)(6) 2024, the patient underwent an initial open reduction internal fixation (orif surgery) for the fibula fracture (ao classification: 44-c).The surgeon inserted the single screw for fixation to the fracture, but it broke off under the screw head during insertion.The surgeon judged that the removing the broken screw was impossible, and the broken screw was remained in the body at the surgeon¿s discretion.Only the screw head was removed from the body.The surgery was completed successfully with no surgical delay.The surgeon commented that the patient was young and had good bone quality.Patient is listed as stable.This report is for 2.7mm ti cortex screw slf-tpng with t8 stardrive recess 20mm this is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohnackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19623855
• Report Number: 8030965-2024-07978
• Device Sequence Number: 12352215
• Product Code: HWC
• UDI-Device Identifier: 10886982206749
• UDI-Public: (01)10886982206749
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 402.880S
• Device Lot Number: 8L37935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 85 KG